MAUDE Adverse Event Report: EXACTECH, INC. NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Osteolysis (2377)
Date of Event	09/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, this female patient is 8 yrs postop the initial rtha.Poly wire out in 4 years requiring exchange in 4 yrs ago.She¿ now has right right groin pain and osteolysis.May need to revise her entire cup.No other information available at this time.
Additional Manufacturer Narrative
(h3) the patient involved who underwent initial total hip replacement in 2013 and a revision due to acetabular liner wear in 2017 was revised (mfr# 1038671-2017-00272) again approximately 8 years after the index surgery and 4 years after the first revision due to prosthesis wear and osteolysis.The prosthesis wear and osteolysis was able to be confirmed from the provided radiograph.Based on the available information, the patient involved meets the following risk criteria for early prosthesis wear/osteolysis, significant edge loading of the femoral head on the acetabular liner due to excessive cup inclination and implanted with a component having a shelf age of greater than 2 years.The most likely cause for the revision reported due to early prosthesis wear and osteolysis is a combination of the risk factors in patients with increased risk tend to present with signs for prosthesis wear and subsequent particle-induced osteolysis within the first 5 years after the index arthroplasty and have the following characteristics: significant edge loading of the femoral head on the acetabular liner, patients implanted with a lateralized liner, patients in whom the largest available femoral head and/or thinnest available acetabular liner was used, and patients implanted with a component having a shelf age of greater than 2 years.Those patients having a combination of risk factors will have the highest risk for early wear and lysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections d1, d4, d10, g3, g4, g6, h2 and h4 have been updated accordingly.Section d1: brand name.Section d4: model number, catalog number, serial number, expiration date, unique identifier (udi) # section g4: pma/510(k)number.Section h4: device manufacture date.Section d10: concomitant medical products cocr fem head 28mm +0 offset 12/14 (cat# 142-28-00 / serial# (b)(6)) nv crown cup clstr hole 48mm group 1 (cat# 180-01-48 / serial# (b)(6)) pf stem tapered plasma sz 13 (cat# 160-00-13 / serial# (b)(6)).Additional information, including the product investigation, will be submitted within 30 days of receipt.

• Brand Name: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 12616909
• Report Number: 1038671-2021-00527
• Device Sequence Number: 19189535
• Product Code: JDI
• UDI-Device Identifier: 10885862022066
• UDI-Public: 10885862022066
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/04/2018
• Device Model Number: NV GXL LINR, NTRL, 28MM ID, GROUP 1 CUPS
• Device Catalogue Number: 130-28-51
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 04/01/2022; 06/10/2022
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 05/25/2022; 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female